Amniotic membrane extract eye drops: a new approach to severe ocular surface pathologies

Area of Science:

• Ophthalmology
• Regenerative Medicine
• Biomaterials

Background:

• Severe ocular surface pathologies often present refractory symptoms despite conventional treatments.
• Amniotic membrane extract eye drops (AMEED) offer a novel therapeutic approach.
• A standardized protocol for AMEED preparation and topical administration has been established.

Purpose of the Study:

• To assess the safety and efficacy of AMEED in patients with severe ocular surface disorders.
• To evaluate the impact of AMEED on patient-reported symptoms and objective clinical signs.
• To determine the tolerability and adverse event profile of AMEED.

Main Methods:

• Prospective clinical follow-up of 36 eyes from 25 patients with severe ocular surface conditions.
• Regular topical application of AMEED for at least 4 weeks.
• Assessment of efficacy through patient-reported outcomes (VQF25 questionnaire, symptom scores) and objective clinical measurements, including corneal epithelization.

Main Results:

• AMEED demonstrated a statistically significant improvement in ocular symptoms such as foreign body sensation, itching, and stinging (p < 0.05).
• Complete epithelization was observed in all patients with corneal ulcers.
• While visual quality function scores did not show statistical significance (p = 0.4657), a positive trend was noted.
• The treatment was found to be safe and well-tolerated with no significant adverse events reported.

Conclusions:

• Topically applied AMEED is safe, well-tolerated, and effective in alleviating symptoms and clinical signs of severe ocular diseases.
• AMEED shows particular efficacy in promoting corneal healing in cases of corneal ulcer.
• Further research is warranted to define optimal indications and treatment protocols for AMEED.